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Comparison Between Clear Aligners and Traditional Fixed Appliances in the Treatment of Four-premolar-extraction Cases

Primary Purpose

Malocclusion, Angle Class I, Malocclusion; Displaced or Missing Teeth, Crowding

Status

Completed

Phase

Not Applicable

Locations

Syrian Arab Republic

Study Type

Interventional

Intervention

Fixed Appliances

Clear Aligners

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class I

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Class I malocclusion with severe crowding (more than 5 mm of tooth-size-arch-length-discrepancy).
Good oral hygiene and periodontal health.
No severe skeletal discrepancy.
Normal proclination for the upper and lower incisors.
No congenitally missing or extracted teeth (except for the third molars).
No history of previous trauma to the maxillofacial region or surgical interventions.

Exclusion Criteria:

Bimaxillary dentoalveolar severe protrusion.
Previous orthodontic treatment.
Subject with psychological abnormalities.
Subject with systemic diseases.
Subject has known allergy to latex and plastic

Sites / Locations

Department of Orthodontics, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

fixed appliances

clear aligners

Arm Description

patients will be treated using fixed appliances in order to align their teeth after extraction of four premolars

patients will be treated using clear aligners in order to align their teeth after extraction of four premolars

Outcomes

Primary Outcome Measures

Change in the American Board of Orthodontics - Objective Grading System (ABO-OGS)

Eight domains are evaluated: Alignment: No more than 2 points shall be subtracted for any tooth when it is poorly aligned; Marginal Ridges: The total number of deductions shall be subtracted from 32 to give the score for this domain; Buccolingual inclination: If the mandibular lingual cusps or maxillary buccal cusps are more than 1 mm from the straight edge surface, 1 point shall be subtracted for that tooth; Occlusal Contacts: If a cusp is out of contact with the opposing arch, 1 point is subtracted for that tooth; Occlusal relationships. The total number of deductions are subtracted from 24 to give the score for occlusal relationships; Overjet; Interproximal contacts. If no interproximal spaces exist, then no points are subtracted; and Root angulation: Any deviations in roots' angulations will cause a deduction form the general score. Finally, a case that loses more than 30 points will be considered a failure. A case that loses less than 20 points will be considered acceptable.

Secondary Outcome Measures

Full Information

NCT ID

NCT03645356

First Posted

August 22, 2018

Last Updated

February 20, 2023

Sponsor

Damascus University

1. Study Identification

Unique Protocol Identification Number

NCT03645356

Brief Title

Comparison Between Clear Aligners and Traditional Fixed Appliances in the Treatment of Four-premolar-extraction Cases

Official Title

Evaluation of the Efficacy of Clear Aligners in the Correction of Severe Dental Crowding Cases Combined With Premolar Extraction Versus Vestibular Fixed Orthodontic Appliances: A Randomized Clinical Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

August 19, 2018 (Actual)

Primary Completion Date

December 10, 2021 (Actual)

Study Completion Date

July 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Patients who have severe crowding that require four premolars extraction will be treated in this study. The efficacy of the clear aligners and vestibular fixed appliances will be assessed. The treatment result of these two different methods will be explored using the Peer Assessment Rating (PAR) in two different times (T0: Before treatment, T1: After treatment) and the American Board of Orthodontics Objective Grading System (ABO-OGS) after treatment (T1). There are two groups: First group (Experimental): the patients in this group will be treated using clear aligners. Second group (Control): the patients in this group will be treated using fixed appliances.

Detailed Description

For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the CAD/CAM technology, clear aligners treat a broader range of cases with greater precision. They consist of a series of plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malocclusion, Angle Class I, Malocclusion; Displaced or Missing Teeth, Crowding

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

fixed appliances

Arm Type

Active Comparator

Arm Description

patients will be treated using fixed appliances in order to align their teeth after extraction of four premolars

Arm Title

clear aligners

Arm Type

Experimental

Arm Description

patients will be treated using clear aligners in order to align their teeth after extraction of four premolars

Intervention Type

Device

Intervention Name(s)

Fixed Appliances

Intervention Description

Using an MBT-prescription of metallic brackets, patients will be treated in the conventional way

Intervention Type

Device

Intervention Name(s)

Clear Aligners

Intervention Description

Using a sequence of clear aligners, patients will be give an aligner every two weeks until the completion of treatment

Primary Outcome Measure Information:

Title

Change in the American Board of Orthodontics - Objective Grading System (ABO-OGS)

Description

Time Frame

T1: one day before the commencement of treatment. T2: one day following the end of treatment (that is expected to happen within 24 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Class I malocclusion with severe crowding (more than 5 mm of tooth-size-arch-length-discrepancy). Good oral hygiene and periodontal health. No severe skeletal discrepancy. Normal proclination for the upper and lower incisors. No congenitally missing or extracted teeth (except for the third molars). No history of previous trauma to the maxillofacial region or surgical interventions. Exclusion Criteria: Bimaxillary dentoalveolar severe protrusion. Previous orthodontic treatment. Subject with psychological abnormalities. Subject with systemic diseases. Subject has known allergy to latex and plastic

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samer T Jaber, DDS MSc

Organizational Affiliation

PhD Student in Orthodontics, University of Damascus Dental School, Damascus

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohammad Y Hajeer, DDS MSc PhD

Organizational Affiliation

Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Orthodontics, University of Damascus Dental School

City

Damascus

ZIP/Postal Code

DM20AM18

Country

Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

14614415

Citation

Bollen AM, Huang G, King G, Hujoel P, Ma T. Activation time and material stiffness of sequential removable orthodontic appliances. Part 1: Ability to complete treatment. Am J Orthod Dentofacial Orthop. 2003 Nov;124(5):496-501. doi: 10.1016/s0889-5406(03)00576-6.

Results Reference

background

PubMed Identifier

22928114

Citation

Drake CT, McGorray SP, Dolce C, Nair M, Wheeler TT. Orthodontic tooth movement with clear aligners. ISRN Dent. 2012;2012:657973. doi: 10.5402/2012/657973. Epub 2012 Aug 14.

Results Reference

background

PubMed Identifier

19904051

Citation

Giancotti A, Di Girolamo R. Treatment of severe maxillary crowding using Invisalign and fixed appliances. J Clin Orthod. 2009 Sep;43(9):583-9; quiz 582. No abstract available.

Results Reference

background

PubMed Identifier

25939782

Citation

Hennessy J, Al-Awadhi EA. Clear aligners generations and orthodontic tooth movement. J Orthod. 2016 Mar;43(1):68-76. doi: 10.1179/1465313315Y.0000000004.

Results Reference

background

PubMed Identifier

19121497

Citation

Kravitz ND, Kusnoto B, BeGole E, Obrez A, Agran B. How well does Invisalign work? A prospective clinical study evaluating the efficacy of tooth movement with Invisalign. Am J Orthod Dentofacial Orthop. 2009 Jan;135(1):27-35. doi: 10.1016/j.ajodo.2007.05.018.

Results Reference

background

PubMed Identifier

26221410

Citation

Li W, Wang S, Zhang Y. The effectiveness of the Invisalign appliance in extraction cases using the the ABO model grading system: a multicenter randomized controlled trial. Int J Clin Exp Med. 2015 May 15;8(5):8276-82. eCollection 2015.

Results Reference

background

PubMed Identifier

26629473

Citation

Zhang XJ, He L, Guo HM, Tian J, Bai YX, Li S. Integrated three-dimensional digital assessment of accuracy of anterior tooth movement using clear aligners. Korean J Orthod. 2015 Nov;45(6):275-81. doi: 10.4041/kjod.2015.45.6.275. Epub 2015 Nov 20.

Results Reference

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Comparison Between Clear Aligners and Traditional Fixed Appliances in the Treatment of Four-premolar-extraction Cases

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